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Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection
- Source :
- American Journal of Clinical Pathology
- Publication Year :
- 2020
- Publisher :
- Oxford University Press (OUP), 2020.
-
Abstract
- ObjectivesTo evaluate the analytical and clinical performance of the Truvian Easy Check coronavirus disease 2019 (COVID-19) IgM/IgG anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody test.Serologic assays have become increasingly available for surveillance through the Food and Drug Administration emergency use authorization in the ongoing COVID-19 global pandemic. However, widespread application of serologic assays has been curbed by reports of faulty or inaccurate tests. Therefore, rapid COVID-19 antibody tests need to be thoroughly validated prior to their implementation.MethodsThe Easy Check device was analytically evaluated and its performance was compared with the Roche Elecsys anti-SARS-CoV-2 antibody assay. The test was further characterized for cross-reactivity using sera obtained from patients infected by other viruses. Clinical performance was analyzed with polymerase chain reaction-confirmed samples and a 2015 prepandemic reference sample set.ResultsThe Easy Check device showed excellent analytical performance and compares well with the Roche Elecsys antibody assay, with an overall concordance of 98.6%. Clinical performance showed a sensitivity of 96.6%, a specificity of 98.2%, and an overall accuracy of 98.1%.ConclusionsThe Easy Check device is a simple, reliable, and rapid test for detection of SARS-CoV-2 seropositivity, and its performance compares favorably against the automated Roche Elecsys antibody assay.
- Subjects :
- 0301 basic medicine
Emergency Use Authorization
IgM
Coronavirus disease 2019 (COVID-19)
IgG
Concordance
Cross Reactions
Antibodies, Viral
medicine.disease_cause
Sensitivity and Specificity
Immunoglobulin G
COVID-19 Serological Testing
03 medical and health sciences
0302 clinical medicine
Humans
Medicine
030212 general & internal medicine
Diagnostics
Lateral flow
Point of care
Coronavirus
Surveillance
SARS-CoV-2 antibodies
biology
SARS-CoV-2
business.industry
COVID-19
General Medicine
030104 developmental biology
Immunoglobulin M
Point-of-care
Immunology
biology.protein
Original Article
Antibody
business
AcademicSubjects/MED00690
Subjects
Details
- ISSN :
- 19437722 and 00029173
- Volume :
- 155
- Database :
- OpenAIRE
- Journal :
- American Journal of Clinical Pathology
- Accession number :
- edsair.doi.dedup.....89901ec4eb19e22e7066761cce9b574d